Smoking cessation effectiveness in smokers with COPD and asthma under real life conditions

Respiratory Medicine (2014) 108, 577e583

Available online at www.sciencedirect.com

ScienceDirect journal homepage: www.elsevier.com/locate/rmed

Smoking cessation effectiveness in smokers with COPD and asthma under real life conditions Ch Gratziou a,*, A. Florou a,1, E. Ischaki b,2, K. Eleftheriou b, A. Sachlas c, S. Bersimis c, S. Zakynthinos b a Smoking Cessation Clinic, Pulmonary and Critical Care Department, Medical School, University of Athens, Athens, Greece b Pulmonary and Critical Care Department, Medical School, Evaggelismos Hospital, University of Athens, Athens, Greece c Department of Statistics and Insurance Science, University of Piraeus, Piraeus, Greece

Received 4 August 2013; accepted 15 January 2014

Available online 2 February 2014

KEYWORDS Smoking cessation; COPD; Asthma; Respiratory diseases; Real life studies

Summary Introduction: Although smoking cessation is strongly indicated by international guidelines as an effective therapeutic tool for patients with COPD and Asthma, a large proportion of them do not quit smoking and they are regarded as a "difficult" target group. Aim: To study the effectiveness of an intensive smoking cessation program in smokers with COPD and asthma under real-life conditions. Methods: 166 smokers with COPD, 120 smokers with asthma and 1854 control smokers attended the smoking cessation program in the out-patient patient Smoking Cessation Clinic of the Pulmonary Department in Athens University. Continuous Abstinence Rate (CAR) was evaluated in 3, 6, 9 and 12 months after the target quit date. Results: Short-term CAR (in 3 months) was 49.4% for COPD smokers, 51.7% for asthmatic smokers and 48.0% for the control group of smokers. 12 months after the initial visit the CAR was 13.9%, 18.3% and 15.9%, respectively. No statistically significant differences between groups at any study period were found. Smokers with good compliance with the program had higher long-term CAR after 12 months: 37.7% in COPD smokers, 40.0% in asthmatic smokers and 39.3% in control smokers. High CAR was observed at all stages of COPD severity.

* Corresponding author. School of Medicine, National and Kapodistrian University of Athens, Smoking Cessation Centre, Evgenidio Hospital, 20 Papadiamantopoulou Str, 11528 Athens, Greece. Tel.: þ30 210 7236743; fax: þ30 2107242785. E-mail addresses: [email protected], [email protected] (C. Gratziou). 1 Smoking Cessation Centre, Evgenidio Hospital, School of Medicine, National and Kapodistrian University of Athens, 20 Papadiamantopoulou Str, 11528 Athens, Greece. 2 Pulmonary Clinic of Pulmonary and Critical Care Department, General Hospital of Evaggelismos, School of Medicine, National and Kapodistrian University of Athens, 45e47 Ipsilantou Str, 10676 Athens, Greece. 0954-6111/$ - see front matter Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.rmed.2014.01.007

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C. Gratziou et al. Conclusion: The results support the view that smokers with respiratory obstructive airway diseases of any severity should be offered an intensive smoking cessation program with regular and long-term follow-up. This will help them to achieve high abstinence rates and prevent relapses. Published by Elsevier Ltd.

Introduction

Method

Cigarette smoking is a major preventable risk factor for respiratory obstructive airway diseases (ROAD), mainly represented by Chronic Obstructive Pulmonary Disease (COPD) and asthma [1]. COPD is a significant and growing cause of morbidity and mortality with smoking being recognized as its most important causative factor [2,3]. It is estimated that by 2020, it will become the 3rd leading cause of death [4]. COPD current smokers have higher prevalence of respiratory symptoms, greater annual rate of decline in FEV1, and higher death rates for COPD than nonsmokers [2,5]. Active smoking as a risk factor for developing asthma remains to be elucidated, although epidemiological and family studies have indicated that genes predisposing to asthma interact with environmental tobacco smoke (ETS) exposure in early life. [1,6] Asthmatic smokers have more severe asthma symptoms, increased risk of asthma attacks and exacerbations, a shift to inflammatory phenotype from eosinophilia towards neutrophilia, increased risk of death, and a degree of steroid-resistance with significant effect to treatment response [7,8]. Smoking cessation is the most important therapeutic intervention in patients at all stages of COPD, since it is the only intervention that slows down the disease progression and improves respiratory symptoms [2,9]. In asthmatic patients, smoking cessation improves lung function, asthma symptoms, and treatment outcome. It also significantly improves the asthma specific quality of life score [7,10,11]. Although smokers with respiratory complaints seem more motivated to quit smoking than those with no such complaints [12], a large proportion of them e especially patients with severe COPD e do not quit smoking and require support [13]. Usually, respiratory patients develop “tolerance” to repeated quit advice [6]. They also have relatively high prevalence of depression or low mood [14,15], higher nicotine dependence score [16,17] and more fear of weight gain [6]. Furthermore in advanced stages of COPD, quality of life is low and the smoking patient considers cigarettes as one of the few things left that improve quality of life [6]. The aim of our study was to evaluate the effectiveness of an intensive smoking cessation program, in real world clinical practice with currently approved pharmacological treatment and counseling in smokers with ROAD (COPD and Asthma). As primary endpoint, we considered the shortterm Continuous Abstinence Rates (CARs) in 3 months after Target Quit Date (TQD), while as a secondary endpoint, we considered the long-term abstinence 6, 9 and 12 months after TQD.

This was a retrospective, observational, real life, study that recruited smokers from the out-patient Smoking Cessation Clinic of the Pulmonary Department in Athens University. The study conducted from 2009 to 2012 and was approved by the ethical committee of the hospital.

Subjects e study population During the study period, 2140 adults Caucasian smokers, selected from smokers who voluntarily visited the Smoking Cessation Clinic, were enrolled in the study. All participants were >18 years, self-motivated to stop smoking and were smoking 10 cigarettes per day for at least 5 years. 286 had a history of chronic respiratory obstructive airway disease previously diagnosed by a physician: 166 of current smokers had COPD and 120 had a long time history of persistent allergic asthma. Smokers with COPD (persistent airway obstruction FEV1/FVC <70%) were classified according to the GOLD classification into 4 stages (stage I: FEV1 >80% pred, stage II: FEV1 50%e80% pred, stage III: FEV1 30%e50%, stage IV: FEV1 <30%) [18]. Stages III and IV were combined for statistical analysis due to a small number of COPD patients at stage IV (only 2 subjects). Asthmatic smokers had a history of well controlled asthma, as it is defined according to GINA guidelines [19]. Patients with unstable or undiagnosed respiratory disease were excluded from the study. The control group consisted of smokers without any respiratory symptoms and no history of pulmonary, cardiovascular or psychiatric disease.

Study protocol The study protocol included a first baseline visit, four weekly follow-ups and finally a follow-up visit every 4 weeks up to 12 weeks. Then, a long-term follow-up was scheduled every 3 months up to 12 months. Baseline visit A thorough personal and clinical assessment was held by a respiratory physician, specialized in smoking cessation during the first visit. The duration of the initial visit was about 60 min. Initially, every participant completed specific questionnaires regarding (a) smoking habits, (b) nicotine dependence assessment performed by the Fagerstro ¨m test for nicotine dependence [20] (FTND score 1e10), (c) motivation and self-efficacy to quit smoking by asking and rating the following three questions i) How difficult is quitting smoking? ii) How much do you want to stop smoking? iii) How confident do you feel that your attempt will be successful? Assessment score in a scale from 1 to 10 [6].

Smoking cessation effectiveness in COPD and asthma (d) Withdrawal symptoms (through the DSM-IV e Diagnostic and Statistical Manual of Mental Disorders-IV e withdrawal scale) [21]. The smoking status was confirmed by measuring the exhaled carbon monoxide (CO) using CO analyzer [22]. Smokers were allocated to one of four smoking cessation treatments based on their preference, the physician’s choice according to international guidelines, the smoker’s medical history, and other concomitant medication [6,23e25]. The 4 treatments were : Nicotine Replacement Therapy (patch, inhaler, gum, sublingual tablet or any combination) for 12 weeks, Bupropion SR for 8 weeks (150 mg once daily for the first week and 150 mg bd for the rest 8 weeks), and Varenicline for 12 weeks (0.5 mg once daily for the first 3 days, 0.5 mg bd for 4e7 day and 1 mg bd for the rest 11 weeks). A Target Quit Date (TQD) was set between 10 and 15 days after the baseline visit. Follow-up visits Nine follow-up visits were scheduled per protocol: once every week for the first month, then one every 4 weeks up to 12 weeks (3 months) and finally one every three months (at month 6, 9 and 12) after the TQD. If a smoker had missed a visit, a telephone contact was made to re-schedule the appointment, as soon as possible. Between the regular visits, the smoker could make an additional contact. In every visit, the DSM IV withdrawal scale was completed, while smoking status was confirmed by exhaled CO e with CO 10 ppm to indicate that the subject was an active smoker. Body weight and blood pressure were also recorded. Psychological and behavioral interventions were given at every follow-up visit, according to personal needs to prevent relapses, reinforce the quit effort, and discuss possible withdrawal symptoms. A physician and a psychologist with a special training on smoking cessation [26] provided an individual personalized counseling with duration of at least 30 min.

Statistical analysis Continuous variables are presented as mean  sd. Chi square test, t-test or analysis of variance were used to evaluate baseline differences in demographic and smoking history variables. Chi square test was used to assess differences in abstinence rates between groups (COPD, asthma and control smokers). Two-tailed p values of <0.05 were considered statistically significant. Table 1

579 Table 2 Stages of severity of disease in smokers with COPDa (by GOLDb classification). Disease severity

Patients number (%)

Stage I (FEV1% pred. >80%) Stage II (FEV1% pred. 50% to 80%) Stage III & IV (FEV1% pred. <50%)

49 (29.5%) 44 (26.5%) 73 (44.0%)

c

a b c

COPD: Chronic obstructive pulmonary disease. GOLD: Global initiative for chronic Obstructive Lung Disease. FEV1: Forced expiratory volume in 1 s.

Results Patient’s data Baseline characteristics of the study population are presented in Table 1. Between smokers with ROAD and control smokers, a statistically significant difference in age (p < 0.001), packs per year (p Z 0.001) and DSM-IV (p Z 0.049) was found. Smokers with COPD and asthma had higher mean age, smoked more cigarettes (packs per year), and had higher DSM-IV score. Age and smoking history (packs per year) were statistically significantly higher in COPD group than in asthmatics (p < 0.001). DSM-IV score was similar between those two groups. Nicotine dependence was severe (FDNT > 7) in all groups of smokers with no statistically significant difference among them. Motivation and selfconfidence to quit was not different in between the study groups. The distribution between male and female was almost equal in both groups of smokers with respiratory disease and control group of smokers (48.6% and 51.4% were men in smokers with asthma-COPD and control group, respectively). No statistically significant difference in the proportion of two genders was found neither in smokers with respiratory diseases (p Z 0.565) nor in control smokers (p Z 0.090). Severity stages for COPD are shown in Table 2.

CAR in the whole (intention-to-treat) study population CAR in the intention-to-treat (IT) study population was calculated based on the total number of subjects, who attended the program even for one or two visits. Table 3

Demographics and smoking attitudes characteristics of the study population.

Age Cigarettes/day Packs/year FDNTc DSM-IVd Motivation scale

COPDa (n Z 166)

Asthma (n Z 120)

ROADb (n Z 286)

Control (n Z 1854)

55.4 (9.3) 38.0 (18.1) 66.7 (38.3) 7.1 (1.8) 15.0 (7.8) 8

41.9 (10.0) 32.7 (15.3) 37.0 (29.7) 7.0 (2.1) 14.5 (7.4) 9

49.7 (11.8) 36.0 (17.0) 54.5 (37.8) 7.1 (1.9) 14.7 (7.6) 8.5

45.7 (10.4) 33.3 (14.4) 43.6 (27.0) 7.1 (2.0) 13.4 (7.6) 8

Data are expressed as mean  sd. a COPD: chronic obstructive pulmonary disease. b ROAD: Respiratory obstructive airway diseases (COPD and asthma). c FDNT: Fagerstro ¨m Test for Nicotine Dependence. d DSM-IV: Diagnostic and Statistical Manual of Mental Disorders IV.

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Table 3 Continuous Abstinence Rate at 3 months (end of pharmacological treatment) and at 6, 9, 12 months after Target Quit Date (TQD) in smokers with ROAD vs control group and in smokers with COPD vs asthmatic smokers in the whole study population. CARa, n(%)

3 months

6 months

9 months

12 months

Control group Smokers with ROADb p-Value Smokers with COPDc Smokers with asthma p-Value

890 (48.0%) 145 (50.7%) 0.425 82 (49.4%) 63 (51.7%) 0.796

549 (29.6%) 89 (31.2%) 0.632 48 (28.9%) 41 (34.2%) 0.414

454 (24.5%) 81 (28.4%) 0.191 44 (25.9%) 37 (30.8%) 0.434

295 (15.9%) 45 (16.0%) 0.999 23 (13.9%) 22 (18.3%) 0.389

a b c

CAR: Continuous Abstinence Rate. ROAD: Respiratory Obstructive Airway Disease (COPD and asthma). COPD: Chronic Obstructive Pulmonary Disease.

comparable with the IT population with no statistically differences neither between smokers with ROAD and controls (59.3% and 56.8% respectively, p Z 0.500) nor between COPD and asthmatics (59.4% and 57.9% respectively, p Z 0.919). However, CAR at 12 months was more than double in all study groups for the smokers with good compliance. Fig. 1a and b present CAR in smokers with COPD and asthma with respect to the duration of attendance to the program with compliance to treatment (1e3 weeks, 4e7 weeks and >8 weeks). The longer the attendance with better compliance to treatment was, the higher the abstinence rates were. After 1 year, CAR were 6.3% (n Z 1) vs 54.1% (n Z 20) in COPD smokers and 11.1% (n Z 2) vs 54.8% (n Z 17) in asthmatic smokers, who took medication treatment for less than 3 weeks and more than 8 weeks, respectively. Comparison between treatment arms is not presented, as the treatment was not randomly selected, but personalized according to the needs and doctors choice.

presents the short-term CAR (at 3 months after TQD) and the long-term CAR (at 6, 9, and 12 months following TQD). Smokers were considered as quitters, if they did not smoke at all after the TQD. Short-term CAR was 49.4% for the COPD patients, 51.7% for the asthmatic smokers, and 48.0% for the controls. These differences were not statistically significant between the smokers with COPD and the asthmatics (p Z 0.796) or between the smokers with ROAD and the controls (p Z 0.425) (Table 3). The long-term CAR was also not statistically significantly different between COPD and asthmatic smokers or between smokers with ROAD and control group of smokers at 6, 9, and 12 months (Table 3). No statistically significant differences in the abstinence rates at any time during the study between men and women among the three groups of smokers (control, COPD, asthma) were found.

CAR according to compliance to the program

CAR among COPD smokers according to disease severity (GOLD stages)

Smokers were considered to have good compliance to the intensive program if they had at least 4 visits during for the first treatment period, more than 4 weeks of pharmacological treatment and 3 regular visits during the follow-up study period up to 12 months. Table 4 presents the short-term and long-term CAR for smokers with good compliance. CAR at 3 months were

Table 5 presents the abstinence rates in COPD smokers with respect to disease severity (defined by GOLD 2010). The CAR for stages I and II of COPD are comparable with those for controls in all study periods. COPD smokers with severe

Table 4 Continuous Abstinence Rate at 3 months (end of pharmacological treatment) and at 6, 9, 12 months after Target Quit Date (TQD) in smokers with ROAD vs control group and in smokers with COPD vs asthmatic smokers in smokers with good compliance to the program. CARa, n(%)

3 months

6 months

9 months

12 months

Control smokers Smokers with ROADb p-Value Smokers with COPDc Smokers with asthma p-Value

890 (56.8%) 144 (59.3%) 0.500 82 (59.4%) 62 (57.9%) 0.919

549 (52.1%) 89 (56.4%) 0.361 48 (55.2%) 41 (56.9%) 0.949

454 (46.6%) 80 (51.9%) 0.249 43 (50.6%) 37 (51.4%) 0.999

295 (39.3%) 45 (39.5%) 0.999 23 (37.7%) 22 (40.0%) 0.950

a b c

CAR: Continuous Abstinence Rate. ROAD: Respiratory obstructive airway disease (COPD and asthma). COPD: Chronic Obstructive Pulmonary Disease.

Smoking cessation effectiveness in COPD and asthma

Figure 1 a. CAR at 3, 6, 9 and 12 months after TQD in smokers with COPD. b. CAR at 3, 6, 9 and 12 months after TQD in smokers with asthma.

respiratory impairment (GOLD stages III and IV) have high short-term abstinence rates at 3, 6, and 9 months. After 1 year, the rates remain high and similar to those of smokers with milder COPD stages and controls.

Discussion In the present observational study, we examined the effectiveness of an intensive, smoking cessation program in patients with ROAD under real life conditions. Medical and psychological counseling combined with the approved first line pharmacological treatment [6,23e25] against nicotine dependence were included in the program with regular follow-up visits for a year. The results of this real life study showed high short-term CAR in patients with ROAD that was not different from CAR in smokers without a disease. The abstinence rates were comparable with the CAR referred in previous randomized control clinical studies for patients with COPD [27e29]. To the best of our knowledge, there are not many studies looking for the abstinence rates in asthmatic smokers.

Table 5 Continuous Abstinence Rates (CAR) at 3, 6, 9 and 12 months after Target Quit Date (TQD) for COPD smokers with good compliance to the program according to GOLD stages of the disease. CARa

3 months 6 months 9 months 12 months

Stage I 24 (55.8%) 13 (46.4%) 12 (42.9%) 9 (39.1%) Stage II 23 (60.5%) 9 (47.4%) 6 (33.3%) 5 (33.3%) Stages III & IV 35 (61.4%) 26 (65.0%) 25 (64.0%) 9 (39.1%) a

CAR: Continuous Abstinence Rate.

581 In a double-blind, placebo-controlled multicenter study by Tashkin et al. investigating the efficacy of varenicline in patients with mild to moderate COPD, an abstinence rate of 42.3% is referred at the end of the treatment and 18.6% through weeks 9e52 [29]. Tonnesen et al. report 14.0% CAR for COPD patients after 1 year, using nicotine sublingual tablets [28] and Wagena et al. 28.0% at 26th week using bupropion SR [27]. The higher but no statistically different abstinence rates in our smoker patients compared with controls may be due to the fact that our patients were highly motivated to quit smoking. Because they regularly visited the chest clinic for their usual care of the disease, the same team of doctors repeatedly and strongly advised them to quit smoking. It is well known that the most difficult issue in the process of quitting is to remain abstinent from smoking. The smoker’s progress during the first period of a quit attempt is very important for the long-term abstinence [30]. The intensity of a smoking cessation program and the compliance to the medication treatment are important factors as well. Our results suggest that regular and close follow-up during the first period of a quit attempt is very crucial for the longterm abstinence. The regular follow-up visits during the first 3 months are very important for a successful quit attempt: the physician can enhance the motivation, help and support the smoker to overcome personal fears by discussing behavioral changes and withdrawal symptoms due to nicotine addiction, check the compliance to treatment and possible side effects, control and prevent factors that can lead a smoker to relapse. Our study showed that if smokers who want to quit use medication adequately in time (more than 8 weeks) can achieve a very high CAR. Previously reported meta-analyses [6,23] have documented a strong relationship between abstinence and the duration of each clinic visit, the number of sessions, and total contact time in population of smokers from general population. This seems to be more important in smokers with chronic illness, such as smokers with respiratory diseases, that are more reluctant to try to overcome difficulties in quitting, as they are less motivated, more depressed, have frequently other comorbidities, and take concomitant medications [14,15,17,20]. For all these reasons, they need a close follow-up and medical support. Another interesting finding of our study is that high CAR was observed in all COPD smokers irrespectively of the severity of their disease. Even severe COPD smokers (stages III and IV) can have the same abstinence rates as smokers at the earlier stages of the disease (I and II) and as the control group of smokers, if they can follow an intensive supportive program. Our results are relevant to those referred by Jimenez-Ruiz et al. [31] as far as the effectiveness and safety of drug treatment for smoking cessation in smokers with severe and very severe COPD with high continuous abstinence rates (48.5%) in 24 weeks after the quit date. Special care and more intensive interventions are suggested to increase success rate of smoking cessation among smoking patients with chronic respiratory disease [32]. In a Swedish study, COPD patients that smoked were hospitalized for 11 days with the aim of getting them to quit smoking. They were prescribed NRT and offered counseling for 1 h daily. The quit rate after 1 year was 52.0% for hospitalization and 7.0% for usual care [33]. Our intensive

582 smoking cessation program with the regular follow-up visits within an out-patient clinic seems to give high smoking cessation efficacy and is more easily applicable and acceptable by the majority of smoker patients. Furthermore, the hospitalization may cost more for the health system. Compared with the general population, smokers with respiratory airway obstructive diseases are considered as a difficult target group. One of the reasons may be the high prevalence of depression [14,15,34], which is independently associated with smoking [35] and failure to give it up [36]. Depression is also one of the withdrawal symptoms that predicts relapse to smoking [37]. The prevalence of depression in COPD patients with severe airway obstruction (FEV1 < 50%) was 25.0% and had 2.5 times greater risk of depression than healthy smokers [15]. Similar findings for asthmatic patients show that individuals with asthma reported more symptoms of depression and especially among those patients with severe asthma [14]. Smoking in these situations may be helpful as a kind of self-medication that controls emotions. Relapsing after a quit attempt may be a way to escape from depressive mood [6,38]. In our study, although we had significant differences in DSM-IV score at baseline between smokers with ROAD and controls with comparable score between smokers with COPD and asthma, we did not find differences in the short-term or long-term CAR. It seems that the strong health motivation, combined with the intensive medical and personal support during a quit attempt can give high abstinence rates in 3, 6, and 12 months, even in patients with severe respiratory disease. The degree of nicotine dependence has been found to predict outcomes in quit attempts [16,17,20]. An epidemiological, multicenter, population-based study showed that smokers with COPD were more dependent on nicotine than healthier smokers (FTND scores 4.7 vs 3.1, respectively; p Z 0.001). The same study reported that only 10.0% of healthy smokers had high dependence, whereas 28.0% of smokers with COPD were highly dependent [20]. Higher levels of nicotine dependence were also found among adolescents with asthma and especially among those with higher symptom severity. This explains the greater number of unsuccessful smoking cessation attempts, compared to those without asthma [17]. However, our study population did not show any difference at the nicotine dependence among smokers with COPD or asthma and the control smokers. High nicotine dependence score (FTND score > 7) was observed in all study groups and was higher than the average score showed in other studies in which the profile of smokers attending a smoking cessation service was described [39,40]. The high nicotine dependence scores did not affect the efficacy of our intensive smoking cessation program neither in control group of smokers nor in the respiratory patients group. Most of the participants of our study were highly motivated to quit smoking and more willing to quit, more confident for their effort as they had previously visited the same chest clinic for their routine disease care and thus the same doctor repeatedly advised them to quit smoking. The behavioral support was adjusted to each individual smoker personal life and medical history. Medication treatment was not randomized, so comparisons of treatment arms

C. Gratziou et al. could not be performed, but prescribed with respect to patient’s needs and will. Despite these limitations, this study provides important information for the effectiveness of a smoking cessation program in patients with respiratory diseases compared to control smokers under real world circumstances, reflecting the routine clinical practice. The study results can help health physicians recognize that smoking cessation is a mandatory first medical intervention and thus, advise smoker patients with chronic respiratory disease to quit smoking. In conclusion, our results showed that it is crucial for smokers with asthma or COPD of any severity to attend an intensive smoking cessation program with regular and longterm follow-up e this will help them achieve high shortterm and long-term abstinence rates and avoid relapses. Regular attendance with frequent follow-up visits mainly for the first three months are important and the combination of medical counseling with individual behavioral support and pharmaceutical treatment can increase abstinence rates through reinforcing the quit effort and overcoming possible withdrawal symptoms. Doctor’s optimistic approach and more motivational tools to increase the patient compliance can be helpful. Quitting smoking is the healthiest intervention to affect the natural progression, the treatment response and quality of life in all respiratory patients.

Conflict of interest All authors do not have any conflict of interest related to the present study.

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